When tested in mice, the vaccine, delivered through a fingertip-sized patch, produces antibodies thought to be sufficient for neutralizing the virus.
“We had previous experience on SARS-CoV in 2003 and MERS-CoV in 2014,” explained Andrea Gambotto, M.D., associate professor of surgery at the Pitt School of Medicine. “These two viruses, which are closely related to SARS-CoV-2, teach us that a particular protein, called a spike protein, is important for inducing immunity against the virus. We knew exactly where to fight this new virus.”
Researchers are using a novel approach to deliver the drug, called a microneedle array, to increase potency. This array is a fingertip-sized patch of 400 tiny needles that delivers the spike protein pieces into the skin, where the immune reaction is strongest. The patch goes on like a Band-Aid and then the needles — which are made entirely of sugar and the protein pieces — simply dissolve into the skin.
Once manufactured, the vaccine can sit at room temperature until it’s needed, eliminating the need for refrigeration during transport or storage. And mass production of the vaccine can be scaled up quickly, scientists say.
Researchers are now in the process of applying for an investigational new drug approval from the U.S. Food and Drug Administration in anticipation of starting a phase I human clinical trial in the next few months.
“Testing in patients would typically require at least a year and probably longer,” said Louis Falo, M.D., Ph.D., professor and chair of dermatology at Pitt’s School of Medicine and UPMC. “This particular situation is different from anything we’ve ever seen, so we don’t know how long the clinical development process will take. Recently announced revisions to the normal processes suggest we may be able to advance this faster.”